Label comparisons began promptly with the accelerated U.S. FDA clearance of Gilead Sciences Inc.’s oral peroxisome proliferator-activated receptor (PPAR)-delta drug, Livdelzi (seladelpar), for primary biliary cholangitis (PBC). The space includes Ipsen Pharma SA’s dual PPAR alpha/delta agonist, Iqirvo (elafibranor), licensed from Genfit SA and cleared in June 2024, as well as Ocaliva (obeticholic acid), the first-in-class farnesoid X receptor agonist from Intercept Pharmaceuticals Inc., greenlighted for PBC in May 2016.
Wall Street promptly started speculating about the product’s odds in the graft-vs.-host disease (GVHD) marketplace shortly after Syndax Pharmaceuticals Inc. and Incyte Corp. scored U.S. FDA approval – well ahead of the Aug. 29 PDUFA date – of Niktimvo (axatilimab), an anti-CSF-1R antibody for the treatment of chronic disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
Cullinan Therapeutics Inc. terminated development of Harbour Biomed Holdings Ltd.’s bispecific B7H4 x 4-1BB immune activator, CLN-418 (HBM-7008), after reviewing phase I data.
China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC.
Tokyo-headquartered Otsuka Pharmaceutical Co. Ltd. said Aug. 1 that it will acquire Boston-based Jnana Therapeutics Inc. through a potential $1.125 billion M&A deal. Under the terms, Otsuka will work to close the transaction by the third quarter of 2024, with $800 million paid out to Jnana shareholders, along with up to $325 million in additional development and regulatory milestones payments.
Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib).
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
With $50 million in hand from Flagship Pioneering, Abiologics Inc. is pairing generative artificial intelligence with high-throughput chemical protein synthesis to attack oncology and immunology indications with Synteins, synthetic proteins that represent a new class of programmable medicines. Avak Kahvejian, co-founder and CEO of Abiologics and general partner at Flagship, told BioWorld that Abiologics stands “at the precipice of a completely new modality.”
The 2024 meeting of the International AIDS Society (IAS), which is being held in Munich this week, began with the announcement of another curative bone marrow transplant. The new case brings the total number of patients cured of HIV via a bone marrow transplant up to 7 since “Berlin patient” Timothy Ray Brown became the first such person in 2007.
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